HIV-Associated LipodystrophyPhase 4NCT00126308
Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy
A Phase 4 study testing poly-L-lactic acid in people with HIV-Associated Lipodystrophy and HIV Infections, run by Kirby Institute at 18 sites in Australia.
Trial summary
This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-Associated Lipodystrophy, HIV Infections
- What is being tested?
- poly-L-lactic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesAustralia
- Study dates
- Nov 2005to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or more with laboratory evidence of HIV-1 infection
- Received combination antiretroviral therapy (minimum of 2 agents)
- Antiretroviral regimen should be stable for at least 12 weeks prior to entry with no changes planned during the first 48 weeks. For subjects not on antiretroviral therapy at entry there should be no intent to commence therapy in first 24 weeks.
- Moderate or severe facial lipoatrophy and lipodystrophy at one or more other sites
- Provide written, informed consent.
Who cannot join
- Active AIDS-defining illness including active HIV wasting
- Active herpes labialis or any acute or currently present chronic skin disease (infection/inflammation) on/near area to be treated
- Currently on anticoagulants or any coagulopathy that would preclude safe deep subcutaneous injections
- Women: pregnant, breastfeeding or have positive pregnancy test or not willing to use adequate contraception if of child-bearing potential
- Concomitant therapy with anabolic steroids (except testosterone replacement), corticosteroids at greater than replacement doses, growth hormone or any currently available or experimental agent to improve appetite or weight
- Testosterone replacement for less than 6 months or at greater than replacement doses
Show all 9Show fewer
- Subjects who have discontinued any prohibited concomitant agent/s must cease this therapy at least 30 days prior to screening.
- Prior use of any facial dermal filling/tissue expansion agent/s
- Any condition which may interfere with ability to comply with study requirements.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Australia18 sites
The Care and Prevention Programme - Adelaide University
Adelaide, South Australia, 5000
Queensland Health - AIDS Medical Unit
Brisbane, Queensland, 4002
Gladstone Road Medical Centre
Brisbane, Queensland, 4101
Dr Doong's Surgery
Burwood, New South Wales, 2134
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Gold Coast Sexual Health Clinic
Gold Coast, Queensland, 4220
Clinic 87
Nambour, Queensland, 4560
Royal Perth Hospital
Perth, Western Australia, 6001
407 Doctors
Sydney, New South Wales, 2010
AIDS Research Initiative
Sydney, New South Wales, 2010
Albion Street Clinic
Sydney, New South Wales, 2010
Holdsworth House General Practice
Sydney, New South Wales, 2010
St. Vincent's Hospital
Sydney, New South Wales, 2010
Taylor Square Private Clinic
Sydney, New South Wales, 2010
Royal North Shore Hospital
Sydney, New South Wales, 2065
Liverpool Health Service
Sydney, New South Wales, 2170
Waratah Clinic, St. George Hospital
Sydney, New South Wales, 2217
Westmead Hospital
Westmead, New South Wales, 2145
About this study
Official title: A Multi-Centre, Open-Label, Randomised Study to Assess the Efficacy, Durability and Safety of Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy (FLASH)
This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.
Read the detailed description
HIV lipodystrophy can be distressing and result in suboptimal antiretroviral (ART) adherence. Physical changes may stigmatise subjects while the negative psychological and social impact has become a major concern. To date, as there is no proven therapy for lipoatrophy, cosmetic interventions for facial lipoatrophy are being studied. Poly-L-lactic acid (PLA) has been shown to be both safe and effective when administered by injection to facial areas.
Study aims are:
- to evaluate the extent and duration of improvement in HIV facial lipoatrophy of PLA injections;
- to evaluate the impact of PLA injections on quality of life and ART adherence in subjects with HIV facial lipoatrophy;
- to evaluate the safety and tolerability of polylactic acid.
100 HIV-infected ART-experienced subjects with facial lipoatrophy will be randomised in a 1:1 ratio at study entry to receive either immediate or deferred treatment (delayed 24 weeks) treatment with PLA. Randomisation will be stratified by age, severity of facial lipoatrophy, current ART (PI or non-PI containing and thymidine- or non-thymidine-containing) and surgeon.
The study has clinical end points monitoring CD4 cell counts, viral loads and adverse events. The study also has psychosocial end points monitoring quality of life.
- Conditions
- HIV-Associated Lipodystrophy, HIV Infections
- Being tested
- poly-L-lactic acid
- Keywords
- HIV, Lipodystrophy, Intervention, Poly-L-lactic acid, HIV facial lipoatrophy, Treatment Experienced
- Medical subject headings
- HIV-Associated Lipodystrophy Syndrome, HIV Infections, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poly-L-lactic acidDevice
Also called Sculptra
immediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials)
poly-L-lactic acidDevice
Also called Sculptra
delayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials)
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | poly-L-lactic acid injections Receives: Device: poly-L-lactic acid |
| Delayed | Active comparator | poly-L-lactic acid injections Receives: Device: poly-L-lactic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).
Measured: 24 weeks
Secondary outcomes (8)
Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan
Measured: 96 weeks
Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity
Measured: 24 and 96 weeks
Change from baseline at weeks 24 and 96 in peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA)
Measured: 24 and 96 weeks
Change from baseline at weeks 24 and 96 in quality of life
Measured: 24 and 96 weeks
Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA
Measured: 24 and 96 weeks
All serious, grade 3 or 4 clinical adverse events and any adverse event leading to change/s in ART or discontinuation of PLA
Measured: 24 and 96 weeks
All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART reported to week 96
Measured: 96 weeks
All AEs attributable to study treatment reported to week 96
Measured: week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startNov 2005
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: no change in primary endpoint at week 48
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-Associated LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales, Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme LLC, Hoffmann-La Roche, AIDS Council of New South Wales
- Investigators
- Andrew Carr, A/Prof, Principal investigator, Immunology and Infectious Disease Unit, St. Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126308
- Sponsor's protocol ID
- V1-0 4-05
- Other IDs
- ACTR012605000132640
- Status last verified
- Mar 2009
- First submitted
- 1 Aug 2005
- Last updated
- 2 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open-Label, Randomised Study to Assess the Efficacy, Durability and Safety of Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy (FLASH)
- ClinicalTrials.gov ID
- NCT00126308
- Acronym / sponsor ID
- V1-0 4-05
- Conditions
- HIV-Associated Lipodystrophy, HIV Infections
- Keywords
- HIV, Lipodystrophy, Intervention, Poly-L-lactic acid, HIV facial lipoatrophy, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no change in primary endpoint at week 48
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales, Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme LLC, Hoffmann-La Roche, AIDS Council of New South Wales
- Study start
- Nov 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 3 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.
Detailed description
HIV lipodystrophy can be distressing and result in suboptimal antiretroviral (ART) adherence. Physical changes may stigmatise subjects while the negative psychological and social impact has become a major concern. To date, as there is no proven therapy for lipoatrophy, cosmetic interventions for facial lipoatrophy are being studied. Poly-L-lactic acid (PLA) has been shown to be both safe and effective when administered by injection to facial areas.
Study aims are:
- to evaluate the extent and duration of improvement in HIV facial lipoatrophy of PLA injections;
- to evaluate the impact of PLA injections on quality of life and ART adherence in subjects with HIV facial lipoatrophy;
- to evaluate the safety and tolerability of polylactic acid.
100 HIV-infected ART-experienced subjects with facial lipoatrophy will be randomised in a 1:1 ratio at study entry to receive either immediate or deferred treatment (delayed 24 weeks) treatment with PLA. Randomisation will be stratified by age, severity of facial lipoatrophy, current ART (PI or non-PI containing and thymidine- or non-thymidine-containing) and surgeon.
The study has clinical end points monitoring CD4 cell counts, viral loads and adverse events. The study also has psychosocial end points monitoring quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Device: poly-L-lactic acidpoly-L-lactic acid injections |
| Delayed | Active comparator | Device: poly-L-lactic acidpoly-L-lactic acid injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or more with laboratory evidence of HIV-1 infection
- Received combination antiretroviral therapy (minimum of 2 agents)
- Antiretroviral regimen should be stable for at least 12 weeks prior to entry with no changes planned during the first 48 weeks. For subjects not on antiretroviral therapy at entry there should be no intent to commence therapy in first 24 weeks.
- Moderate or severe facial lipoatrophy and lipodystrophy at one or more other sites
- Provide written, informed consent.
Key exclusion criteria (9 listed)
- Active AIDS-defining illness including active HIV wasting
- Active herpes labialis or any acute or currently present chronic skin disease (infection/inflammation) on/near area to be treated
- Currently on anticoagulants or any coagulopathy that would preclude safe deep subcutaneous injections
- Women: pregnant, breastfeeding or have positive pregnancy test or not willing to use adequate contraception if of child-bearing potential
- Concomitant therapy with anabolic steroids (except testosterone replacement), corticosteroids at greater than replacement doses, growth hormone or any currently available or experimental agent to improve appetite or weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| poly-L-lactic acidAlso: Sculptraimmediate injections poly-L-lactic acid (4 bilateral treatments - 8 vials) | Device | Immediate |
| poly-L-lactic acidAlso: Sculptradelayed (24 weeks) poly-L-lactic acid injections (4 bilateral treatment - 8 vials) | Device | Delayed |
Primary outcome
The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT).
Time frame: 24 weeks
8 secondary outcomes
Change from baseline at week 96 in facial soft tissue volume as measured by spiral CT scan
Time frame: 96 weeks
Change from baseline at weeks 24 and 96 in physician and patient assessment of facial lipoatrophy severity
Time frame: 24 and 96 weeks
Change from baseline at weeks 24 and 96 in peripheral fat as assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame: 24 and 96 weeks
Change from baseline at weeks 24 and 96 in quality of life
Time frame: 24 and 96 weeks
Change from baseline at weeks 24 and 96 in antiretroviral therapy (ART) adherence and plasma HIV-RNA
Time frame: 24 and 96 weeks
All serious, grade 3 or 4 clinical adverse events and any adverse event leading to change/s in ART or discontinuation of PLA
Time frame: 24 and 96 weeks
All serious, grade 3 or 4 clinical adverse events (AEs) and any event leading to change/s in ART reported to week 96
Time frame: 96 weeks
All AEs attributable to study treatment reported to week 96
Time frame: week 96
Results and safety
The study was stopped early (reason given: no change in primary endpoint at week 48). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2009.
- NCHECR Website (Australia)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Carr, A/Prof principal investigator
Immunology and Infectious Disease Unit, St. Vincent's Hospital, Sydney
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing poly-L-lactic acid in people with HIV-Associated Lipodystrophy and HIV Infections, run by Kirby Institute at 18 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: no change in primary endpoint at week 48). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint at 24 weeks will be change from baseline in facial soft tissue volume as measured by spiral computed tomography (CT). (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2009.